Alcohol DrinkingReACH3NCT04546971
Using Telehealth to Address Alcohol Misuse in HIV Care
A study testing Brief Intervention, Telehealth Counseling and Text messaging in people with Alcohol Drinking and HIV Viremia, run by Brown University at 1 site in United States.
Trial summary
This project will test the effects of a telehealth counseling program on reducing alcohol use and improving HIV viral control among people with HIV who drink heavily. In total, 600 heavy drinkers with HIV will be assigned to either (a) a single session of brief counseling on alcohol use or (b) brief counseling plus… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, HIV Viremia
- What is being tested?
- Brief Intervention, Telehealth Counseling and Text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2021to 13 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In care for HIV at one of 4 participating federally qualified health centers, report at least one heavy drinking day (4+ drinks) or average more than 7 drinks per week in the past 30 days
Who cannot join
- need for supervised alcohol detoxification, as indicated by having a history of severe withdrawal symptoms such as seizures and delirium tremens.
Trial locations and contacts
1 site in 1 country.
About this study
This project will test the effects of a telehealth counseling program on reducing alcohol use and improving HIV viral control among people with HIV who drink heavily. In total, 600 heavy drinkers with HIV will be assigned to either (a) a single session of brief counseling on alcohol use or (b) brief counseling plus referral to a telehealth counseling program that includes multiple sessions of counseling by videoconferencing and text messaging support. To understand the effects of the program, participants' alcohol use, HIV outcomes, and health will be assessed over a 2-year period.
Read the detailed description
The purpose of the proposed study is to test the real-world effectiveness of the ReACH (Reducing Alcohol use and related Comorbidities in HIV care) telehealth counseling protocol in a pragmatic Hybrid Type 1 effectiveness-implementation randomized trial. The study will recruit 600 heavy-drinking PLWH from four federally-qualified health centers in geographically distinct regions across the U.S, which provide services to over 14,000 PLWH. Upon completing enrollment, participants will be randomized to receive either single-session brief intervention (BI) by phone with referral to local treatment when appropriate or BI plus referral to ReACH telehealth counseling (TC). Participants will complete follow-ups through 24 months after baseline to assess longer-term changes in drinking and health outcomes. The study will test the hypothesis that TC compared to BI will result in (a) reduced number of drinks consumed per week and frequency of heavy drinking and (b) increased odds of having an undetectable viral load at 12- and 24-month follow-ups. Secondary outcomes include self-reported ART adherence, engagement in condomless sex with non-exclusive partners, frequency of other substance use, phosphatidylethanol levels (a biomarker of recent alcohol use), and Veterans Aging Cohort Study index scores. The study also will examine potential moderators of TC effectiveness. As a secondary aim, implementation measures corresponding to aspects of the Dynamic Sustainability Framework will be assessed including implementation outcomes of acceptability, appropriateness, and feasibility guided by Proctor's Implementation Outcomes Framework. Thus, this pragmatic Hybrid Type 1 trial will help establish the real-world effectiveness of the ReACH TC intervention while also providing key implementation-related measures and outcomes that will inform future ReACH TC scale up and sustainability.
- Conditions
- Alcohol Drinking, HIV Viremia
- Being tested
- Brief Intervention, Telehealth Counseling, Text messaging
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief InterventionBehavioural
Brief alcohol intervention delivered by telephone or videoconferencing focusing on advising participants to reduce drinking
Telehealth CounselingBehavioural
5 sessions of counseling on alcohol use based on Motivational Interviewing.
Text messagingBehavioural
A daily and then monthly text messaging program designed to help participants monitor drinking, set goals, and reinforce successful reduction or abstinence.
| Study group | Role | What they receive |
|---|---|---|
| Brief intervention | Active comparator | A brief alcohol intervention lasting about 10 minutes, delivered after the baseline assessments. Receives: Behavioral: Brief Intervention |
| Brief Intervention plus Telehealth Counseling | Experimental | A brief alcohol intervention followed by referral to a telehealth counseling protocol including 5 sessions of counseling based on Motivational Interviewing and delivered by videoconferencing. Telehealth counseling extends for up to two years and also includes a text messaging intervention to encourage reductions in drinking. Receives: Behavioral: Brief Intervention; Behavioral: Telehealth Counseling; Behavioral: Text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcoholics drinks consumed per week
Average number of alcoholic drinks consumed per week over the past 30 days
Measured: 12 months
Alcoholics drinks consumed per week
Average number of alcoholic drinks consumed per week over the past 30 days
Measured: 24 months
Number of heavy drinking days
Number of days consuming 4 or more drinks in a day over the past 30 days
Measured: 12 months
Number of heavy drinking days
Number of days consuming 4 or more drinks in a day over the past 30 days
Measured: 24 months
Proportion of participants with a detectable HIV viral load
Viral load test result that indicates HIV virus is detectable in the blood
Measured: 12 months
Proportion of participants with a detectable HIV viral load
Viral load test result that indicates HIV virus is detectable in the blood
Measured: 24 months
Secondary outcomes (6)
Proportion of the past 30 days adherent to antiretroviral therapy
Antiretroviral therapy adherence as assessed by self-report
Measured: 12 months
Proportion of the past 30 days adherent to antiretroviral therapy
Antiretroviral therapy adherence as assessed by self-report
Measured: 24 months
Condomless sex with non-steady partners
Number of days in the past 30 having condomless sex with a non-steady partner
Measured: 12 months
Condomless sex with non-steady partners
Number of days in the past 30 having condomless sex with a non-steady partner
Measured: 24 months
Veterans Aging Cohort Study (VACS) index total score
Index of physiologic health calculated using HIV viral load, CD4 cell counts, liver function, creatinine, hemoglobin, platelets, white blood cell count, and height/weight (for body mass index). Higher scores indicate greater physiologic injury and risk for mortality.
Measured: 12 months
Veterans Aging Cohort Study (VACS) index total score
Index of physiologic health calculated using HIV viral load, CD4 cell counts, liver function, creatinine, hemoglobin, platelets, white blood cell count, and height/weight (for body mass index). Higher scores indicate greater physiologic injury and risk for mortality.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start22 Jun 2021
- Primary completion13 Sep 2026
- Study completion13 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher W. Kahler, Brown University
- Investigators
- Christopher Kahler, PhD, Principal investigator, Brown University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546971
- Sponsor's protocol ID
- 2P01AA019072
- Acronym
- ReACH3
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2020
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared through the National Data Archive. We also will post de-identified data used in the primary analyses of trial outcomes after those have been published.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Telehealth to Address Alcohol Misuse in HIV Care
- ClinicalTrials.gov ID
- NCT04546971
- Acronym / sponsor ID
- ReACH3 / 2P01AA019072
- Conditions
- Alcohol Drinking, HIV Viremia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 13 Sep 2026 (actual)
- Study completion
- 13 Sep 2026 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will test the effects of a telehealth counseling program on reducing alcohol use and improving HIV viral control among people with HIV who drink heavily. In total, 600 heavy drinkers with HIV will be assigned to either (a) a single session of brief counseling on alcohol use or (b) brief counseling plus referral to a telehealth counseling program that includes multiple sessions of counseling by videoconferencing and text messaging support. To understand the effects of the program, participants' alcohol use, HIV outcomes, and health will be assessed over a 2-year period.
Detailed description
The purpose of the proposed study is to test the real-world effectiveness of the ReACH (Reducing Alcohol use and related Comorbidities in HIV care) telehealth counseling protocol in a pragmatic Hybrid Type 1 effectiveness-implementation randomized trial. The study will recruit 600 heavy-drinking PLWH from four federally-qualified health centers in geographically distinct regions across the U.S, which provide services to over 14,000 PLWH. Upon completing enrollment, participants will be randomized to receive either single-session brief intervention (BI) by phone with referral to local treatment when appropriate or BI plus referral to ReACH telehealth counseling (TC). Participants will complete follow-ups through 24 months after baseline to assess longer-term changes in drinking and health outcomes. The study will test the hypothesis that TC compared to BI will result in (a) reduced number of drinks consumed per week and frequency of heavy drinking and (b) increased odds of having an undetectable viral load at 12- and 24-month follow-ups. Secondary outcomes include self-reported ART adherence, engagement in condomless sex with non-exclusive partners, frequency of other substance use, phosphatidylethanol levels (a biomarker of recent alcohol use), and Veterans Aging Cohort Study index scores. The study also will examine potential moderators of TC effectiveness. As a secondary aim, implementation measures corresponding to aspects of the Dynamic Sustainability Framework will be assessed including implementation outcomes of acceptability, appropriateness, and feasibility guided by Proctor's Implementation Outcomes Framework. Thus, this pragmatic Hybrid Type 1 trial will help establish the real-world effectiveness of the ReACH TC intervention while also providing key implementation-related measures and outcomes that will inform future ReACH TC scale up and sustainability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief intervention | Active comparator | Behavioral: Brief InterventionA brief alcohol intervention lasting about 10 minutes, delivered after the baseline assessments. |
| Brief Intervention plus Telehealth Counseling | Experimental | Behavioral: Brief Intervention, Behavioral: Telehealth Counseling, Behavioral: Text messagingA brief alcohol intervention followed by referral to a telehealth counseling protocol including 5 sessions of counseling based on Motivational Interviewing and delivered by videoconferencing. Telehealth counseling extends for up to two years and also includes a text messaging intervention to encourage reductions in drinking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In care for HIV at one of 4 participating federally qualified health centers, report at least one heavy drinking day (4+ drinks) or average more than 7 drinks per week in the past 30 days
Key exclusion criteria (1 listed)
- need for supervised alcohol detoxification, as indicated by having a history of severe withdrawal symptoms such as seizures and delirium tremens.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief InterventionBrief alcohol intervention delivered by telephone or videoconferencing focusing on advising participants to reduce drinking | Behavioural | Brief Intervention plus Telehealth Counseling, Brief intervention |
| Telehealth Counseling5 sessions of counseling on alcohol use based on Motivational Interviewing. | Behavioural | Brief Intervention plus Telehealth Counseling |
| Text messagingA daily and then monthly text messaging program designed to help participants monitor drinking, set goals, and reinforce successful reduction or abstinence. | Behavioural | Brief Intervention plus Telehealth Counseling |
Primary outcome
Alcoholics drinks consumed per week
Time frame: 12 months
Average number of alcoholic drinks consumed per week over the past 30 days
Alcoholics drinks consumed per week
Time frame: 24 months
Average number of alcoholic drinks consumed per week over the past 30 days
Number of heavy drinking days
Time frame: 12 months
Number of days consuming 4 or more drinks in a day over the past 30 days
Number of heavy drinking days
Time frame: 24 months
Number of days consuming 4 or more drinks in a day over the past 30 days
Proportion of participants with a detectable HIV viral load
Time frame: 12 months
Viral load test result that indicates HIV virus is detectable in the blood
Proportion of participants with a detectable HIV viral load
Time frame: 24 months
Viral load test result that indicates HIV virus is detectable in the blood
6 secondary outcomes
Proportion of the past 30 days adherent to antiretroviral therapy
Time frame: 12 months
Proportion of the past 30 days adherent to antiretroviral therapy
Time frame: 24 months
Condomless sex with non-steady partners
Time frame: 12 months
Condomless sex with non-steady partners
Time frame: 24 months
Veterans Aging Cohort Study (VACS) index total score
Time frame: 12 months
Veterans Aging Cohort Study (VACS) index total score
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. Data will be shared through the National Data Archive. We also will post de-identified data used in the primary analyses of trial outcomes after those have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Kahler, PhD principal investigator
Brown University School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention, Telehealth Counseling and Text messaging in people with Alcohol Drinking and HIV Viremia, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcoholics drinks consumed per week (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.